MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2011-06-16 for RADISTOP C11177 UNK manufactured by St. Jude Medical Systems Ab.
[2074486]
A few minutes after the radistop was applied, the compressive belt was released and the pt experienced bleeding. An older radistop was then applied and bleeding was controlled. The pt was reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
[9285034]
We have reviewed our device history record and confirmed that this batch met mfg requirements prior to shipment. The investigation of the actual device did not reveal any deficiencies that could have caused or contributed to the event. The cause of the reported event can therefore not be conclusively determined. The ifu advise the user of that excess part of the velcro strap can be cut or fixed (thread under the compression pad strap).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030904-2011-00007 |
| MDR Report Key | 2139168 |
| Report Source | 01,05,06,07 |
| Date Received | 2011-06-16 |
| Date of Report | 2011-06-16 |
| Date of Event | 2011-05-20 |
| Date Mfgr Received | 2011-05-23 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2011-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANNA JUHLEN |
| Manufacturer Street | PALMBLADSGATAN 10 BOX 3650 |
| Manufacturer City | UPPSALA SE-751 35 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-751 35 |
| Manufacturer Phone | 8161000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADISTOP |
| Generic Name | TOURNIQUET, NONPNEUMATIC |
| Product Code | GAX |
| Date Received | 2011-06-16 |
| Returned To Mfg | 2011-05-13 |
| Model Number | C11177 |
| Catalog Number | UNK |
| Lot Number | 105378 |
| ID Number | UNK |
| Device Expiration Date | 2011-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL SYSTEMS AB |
| Manufacturer Address | PALMBLADSGATAN 10 BOX 6350 UPPSALA SE-75135 SW SE-75135 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-16 |